Positive results for Ultibro Breezhaler at ATS

Vectura Group plc

Positive results for once-daily Ultibro® Breezhaler® versuscombination therapy (tiotropium plus formoterol)

· QUANTIFY study met primary endpoint demonstrating non-inferiority of Ultibro® Breezhaler® vs tiotropium 18 mcg plus formoterol 12 mcg in improving health-related quality of life outcomes1,2

· QUANTIFY study met secondary endpoint demonstrating superiority of Ultibro® Breezhaler® vs tiotropium plus formoterol by improving lung function1,2 

· Ultibro® Breezhaler® provides the convenience of a once-daily fixed-dose combination in a single inhalation device for the treatment of COPD

· Novartis will present 16 respiratory abstracts at the 2014 American Thoracic Society (ATS) International Conference

Chippenham, UK - 21 May 2014: Vectura Group plc (LSE: VEC) ("Vectura"), confirms the information released today by Novartis announcing new data from the QUANTIFY study, which demonstrated the non-inferiority of Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg compared to tiotropium 18 mcg plus formoterol 12 mcg in terms of health-related quality of life (HRQoL) outcomes in moderate-to-severe chronic obstructive pulmonary disease (COPD) patients at week 26.1,2 Positive results from QUANTIFY are part of 16 respiratory abstracts being presented by Novartis at the American Thoracic Society (ATS) International Conference, May 16-21, 2014 in San Diego, CA, USA.

In the QUANTIFY study, which included over 900 COPD patients, once-daily Ultibro® Breezhaler® showed superior improvements in lung function (trough FEV1) at 26 weeks compared to once-daily tiotropium plus twice-daily formoterol in moderate-to-severe COPD patients. Additionally, patients taking Ultibro® Breezhaler® were more likely to demonstrate a clinically meaningful improvement in shortness of breath and health-related quality of life (per protocol set) at 26 weeks compared to tiotropium plus formoterol. The safety and tolerability of Ultibro® Breezhaler® was comparable to the other treatment arm in the study.1,2

COPD affects an estimated 210 million people worldwide3 and is projected to be the third leading cause of death by 2020.4 Symptoms can impose a significant burden on patients and reduce quality of life,5,6 but they are often inadequately managed. Treatments that are easy for patients to take and have reliable dose control whilst effectively managing the symptoms of COPD are important to improve patient outcomes.7-9

QUANTIFY was a 26-week treatment, multicenter, randomised, parallel group, blinded study to assess the efficacy and safety of once-daily Ultibro® Breezhaler® in 934 patients with moderate-to-severe COPD, versus the free-combination of tiotropium 18 mcg plus formoterol 12 mcg. The primary objective was to demonstrate non-inferiority of Ultibro® Breezhaler® in HRQoL as assessed by the St. George's Respiratory Questionnaire-COPD (SGRQ-C) versus tiotropium plus formoterol after 26 weeks of treatment. Secondary endpoints included transition dyspnea index (TDI) score, trough FEV1, forced vital capacity (FVC) and safety and tolerability.1,2

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Enquiries

About Vectura

Vectura is a product development company that focuses on the development of pharmaceutical therapies for the treatment of airways-related diseases (airways diseases). This growing market includes asthma and chronic obstructive pulmonary disease (COPD) and is estimated to be worth in excess of $46 billion worldwide.10

Vectura has eight products marketed by its partners and a portfolio of drugs in clinical development, a number of which have been licensed to major pharmaceutical companies. Vectura has disclosed development collaborations and licence agreements with several pharmaceutical and biotechnology companies, including Novartis, Sandoz (the generics arm of Novartis), Baxter, GlaxoSmithKline, UCB, Ablynx, Grifols and Tianjin KingYork Group Company Limited.

Vectura seeks to develop certain programmes itself where this will optimise value. Vectura's formulation and inhalation technologies are available to other pharmaceutical companies on an out-licensing basis where this complements Vectura's business strategy. For further information, please visit Vectura's website at www.vectura.com.

About Ultibro Breezhaler

Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide) is a novel, once-daily dual bronchodilator approved as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.11 Ultibro® Breezhaler® is a fixed-dose combination of two bronchodilators, indacaterol 110 mcg, a long-acting beta2-adrenergic agonist (LABA) and glycopyrronium 50 mcg, a long-acting muscarinic antagonist (LAMA). Ultibro® Breezhaler® was developed and previously known as QVA149. Clinical trials have shown that Ultibro® Breezhaler® offers statistically significant improvements in bronchodilation compared to treatments widely used as current standards of care, including salmeterol/fluticasone 500/50 mcg, in patients with no history of moderate or severe exacerbations over the last year12-14 and open-label tiotropium 18 mcg. Ultibro® Breezhaler® is currently approved for use in over 30 countries, including the EU, Japan, Canada, Mexico and Australia.

About the NVA237/QVA149 License Agreement with Novartis

NVA237 (glycopyrronium bromide - Seebri® Breezhaler®) was licensed to Novartis in April 2005 by Vectura and its co-development partner, Sosei. To date, Vectura has received $65m from Novartis and, under the terms of the license, could receive up to an additional $122.5m for achievement of regulatory and commercialisation targets for both the monotherapy and the combination product. In addition, royalties on product sales will be received in the event of successful product launches.

About the Novartis COPD portfolio

Novartis is committed to addressing the unmet medical needs of COPD patients and improving their quality of life by providing innovative medicines and devices. The Novartis COPD portfolio includes Onbrez® Breezhaler® / Arcapta™ Neohaler™ (indacaterol), Seebri® Breezhaler® (glycopyrronium bromide) and Ultibro Breezhaler (indacaterol/glycopyrronium bromide), which are all indicated as maintenance treatments for COPD patients. Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei.

Novartis continues development of respiratory products for delivery via the low resistance Breezhaler® inhalation device, which makes it suitable for patients with different severities of airflow limitation.9 The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly.9,11

Ultibro®, Seebri®, Onbrez® and Breezhaler® are registered trademarks of Novartis AG.

About COPD

COPD is a progressive life-threatening disease that makes it hard to breathe, with symptoms that have a destructive impact on patients' function and quality of life.4,15 COPD is often considered to be a disease of later years, but estimates suggest that 50% of those with COPD are now less than 65 years old, resulting in increases in absenteeism, premature retirement and reductions in workforce participation.5,6

Forward-looking statements

This press release contains forward-looking statements, including statements about the discovery, development and commercialisation of products. Various risks may cause Vectura's actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programmes; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

References

1. Geßner C et al. Once-Daily QVA149 Demonstrates Superior Improvements in Lung Function Compared to Tiotropium plus Formoterol: The QUANTIFY Study. [ATS abstract # 50961; Thematic Poster Session D44; Date: May 21, 2014 Time: 8:15 AM-4:30 PM].

2. Korn S et al. Once-Daily QVA149 Improves Dyspnea, Quality of Life and Reduces the Rate of Exacerbations Compared to Tiotropium Plus Formoterol in COPD Patients: The QUANTIFY Study. [ATS abstract # 50965; Thematic Poster Session D44; Date: May 21, 2014 Time: 8:15 AM-4:30 PM].

3. Global Alliance Against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD_Manual/en/. [Accessed 13 May 2014].

4. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Updated 2014. http://www.goldcopd.org/uploads/users/files/GOLD_Report2014_Feb07.pdf. [Accessed 13 May 2014].

5. Fletcher MJ et al. COPD Uncovered: An International survey on the impact of chronic obstructive pulmonary disease (COPD) on a working age population. BMC Public Health 2011;11:612.

6. daCosta M et al. The burden of chronic obstructive pulmonary disease among employed adults. Int J Chron Obstruct Pulmon Dis 2012;7:211-219. Published online 2012 March 19. doi: 10.2147/COPD.S29280. [Accessed 13 May 2014].

7. Bryant et al. Improving medication adherence in chronic obstructive pulmonary disease: a systematic review. Respiratory Research 2013;14:109. Available at: http://respiratory-research.com/content/pdf/1465-9921-14-109.pdf. [Accessed 13 May 2014].

8. Chrystyn H et al. Impact of patients' satisfaction with their inhalers on treatment compliance and health status in COPD. Respir Med 2014;108(2):358-65.

9. Pavkov et al. Characteristics of a capsule based dry powder inhaler for the delivery of indacaterol. CMRO 2010;26; 11:2527-2533. doi:10.1185/03007995.2010.518916. [Accessed 13 May 2014].

10. Pharmaview Commercial Landscape Series Respiratory Decision Resources 2014

11. EMA. 2012. Ultibro Breezhaler EU Summary of Product Characteristics. [Online] 3 October 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002679/WC500151255.pdf [Accessed 13 May 2014].

12. Vogelmeier C et al. Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes versus placebo, indacaterol, glycopyrronium, tiotropium and salmeterol/fluticasone in patients with COPD. [ATS abstract 40759; Session C45; Date: May 21, 2013 Time: 8:15 -10:45].

13. Vogelmeier C et al. Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes. [ERS abstract 851178; Session 82; Date: September 8, 2013 Time: 12:50-14:40].

14. Banerji D et al. Dual bronchodilation with once-daily QVA149 improves dyspnea and health status and reduces symptoms and rescue medication use in patients with COPD: the IGNITE trials. [ERS abstract 851388; Session 346; Date: September 10 2013 Time: 8:30-10:30].

15. Joshi A et al. Symptom burden in chronic obstructive pulmonary disease and cancer. Curr Opin Pulm Med 2012;18:97-103.